DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH

K063206 · Dade Behring, Inc. · LPS · Dec 28, 2006 · Clinical Chemistry

Device Facts

• Record ID: K063206
• Device Name: DIMENSION VISTA HCYS FLEX REAGENT CARTRIDGE; PROTEIN 1 CALIBRATOR; PROTEIN 1 CONTROL LOW, MEDIUM, HIGH
• Applicant: Dade Behring, Inc.
• Product Code: LPS · Clinical Chemistry
• Decision Date: Dec 28, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 862.1377
• Device Class: Class 2

Intended Use

Dimension Vista® HCYS Flex® reagent cartridge: The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum, heparinized and EDTA plasma. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria. Dimension Vista® Protein 1 Calibrator: PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and prealbumin/Transthyretin (PREALB) methods on the Dimension Vista® System. Dimension Vista® Protein 1 Control L, M, H: PROT1 CON L, M, H are assayed intra-laboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and prealbumin/Transthyretin (PREALB) methods on the Dimension Vista® System.

Device Story

Device is an in vitro diagnostic reagent cartridge for quantitative homocysteine measurement on the Dimension Vista System. Input: human serum, heparinized plasma, or EDTA plasma. Principle: competitive immunoassay using particle-enhanced nephelometry; sample homocysteine is reduced to free homocysteine, converted to S-adenosyl-homocysteine (SAH), and competes with conjugated S-adenosyl-cysteine (SAC) for binding to anti-SAH antibody-coated polystyrene particles. Output: scattered light signal inversely proportional to SAH concentration. Used in clinical laboratories by technicians. Healthcare providers use results to diagnose and monitor hyperhomocysteinemia and homocystinuria. Benefits: provides automated, quantitative assessment of homocysteine levels to guide clinical management.

Clinical Evidence

No clinical trials performed. Analytical performance established via bench testing: precision (CLSI EP5-A2), linearity, interference (CLSI EP7-A2), and method comparison (CLSI EP9-A2) against predicate. Method comparison on 215 samples yielded Y = 1.056X + 0.239 (r=0.995).

Technological Characteristics

Particle-enhanced turbidimetric immunoassay. Reagents include dithiothreitol for reduction and anti-SAH antibodies bound to polystyrene particles. System utilizes scattered light detection. Calibrators and controls are human serum-based, multi-analyte products. Designed for automated processing on the Dimension Vista System.

Indications for Use

Indicated for quantitative determination of total homocysteine in human serum, heparinized, and EDTA plasma to aid in diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

Regulatory Classification

Identification

A urinary homocystine (nonquantitative) test system is a device intended to identify homocystine (an analogue of the amino acid cystine) in urine. The identification of urinary homocystine is used in the diagnosis and treatment of homocystinuria (homosystine in urine), a heritable metabolic disorder which may cause mental retardation.

Predicate Devices

• Dade Behring N Latex HCY (k052788)
• Dade Behring N Protein Standard SL (k012470)
• Dade Behring N/T Protein Control SL (k01268)

Submission Summary (Full Text)

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## 510(k) Summary for Dimension Vista® HCYS Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L, M and H

DEC 2 8 2006

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The assigned 510(k) number is: 4043800

- 1. Manufacturer's Name, Address, Telephone, and Contact Person, Date of Preparation:
Manufacturer:

Dade Behring Marburg GmbH Emil-von-Behring Str. 76 35001 Marburg, Germany

Contact Information: Dade Behring Inc. P.O. Box 6101 Newark, Delaware 19714-6101 Attn: Kathleen Dray-Lyons Tel: [phone] Fax: [phone]

Preparation date: October 20, 2006

- 2. Device Name: Dimension Vista® HCYS Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L Dimension Vista" Protein 1 Control L
Dimension Vista" Protein 1 Control M
Classification: Class II; Class II; Class I Product Code: LPS; JIX; JJY Panel: Clinical Chemistry (75)

#### 3. ldentification of the Legally Marketed Device:

Dade Behring N Latex HCY -- K052788 Dade Behring N Protein Standard SL - K012470 Dade Behring N/T Protein Control SL - K012468

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Dade Behring Inc Dimension Vista® HCYS 510(k) Notification

#### Device Description: 4.

#### Dimension Vista® HCYS Flex® reagent cartridge

Bound homocysteine in the sample is reduced to free homocysteine by the action of dithiothreitol, and then converted enzymatically to S-adenosyl-homocysteine (SAH). Conjugated S-adenosylcysteine (SAC), added at the onset of the reaction, competes with the SAH in the sample for bonding by anti-SAH antibodies bound to polystyrene particles. In the presence of SAH, there is either no aggregation or a weak aggregation of particles. In the absence of SAH in the sample, an aggregation of the polystyrene particles by the conjugated SAC occurs. The higher the SAH content of the reaction mixture, the smaller the scattered light signal. The result is evaluated by comparison with a standard of known concentration.

### Dimension Vista® Protein 1 Calibrator

Protein 1 Calibrator is a multi-analyte, liquid, human serum based product containing C3, C4. Homocysteine (HCYS). Immunoalobulin A (IGA). Immunoalobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

### Dimension Vista® Protein 1 Control L, M and H

Protein 1 Control L. M and H are multi-analyte, liguid, human serum based products containing C3, C4, Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM), and Prealbumin / Transthyretin (PREALB).

#### 5. Device Intended Use:

### Dimension Vista® HCYS Flex® reagent cartridge:

The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum. heparinized and EDTA plasma on the Dimension Vista System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

### Dimension Vista® Protein 1 Calibrator:

PROT 1 CAL is an in vitro diagnostic product for the calibration of the C3 complement (C3), C4 complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG). Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

### Dimension Vista® Protein 1 Control L, M and H:

PROT1 CON L. M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), Immunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista®.

#### Medical device to which equivalence is claimed and comparison information: 6.

The Dimension Vista® HCYS Flex® reagent cartridge, Dimension Vista® Protein 1 Calibrator and Dimension Vista Protein 1 Control L. M and H are substantially equivalent to the Dade Behring N Latex HCY assay (K052788), N Protein Standard SL (K012470), and N/T Protein Control SL (K012468), respectively.

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#### 7. Device Performance Characteristics:

The Dimension Vista " HCYS assay was compared to the Dade Behring N Latex HCY
assay on the BN ProSpec" System by evaluating serum and plasma samples with yielded the following equation:

| n | Slope | Intercept | Correlation Coefficient | |
|------------------------|-------|-----------|-------------------------|-------|
| Dimension Vista ® HCYS | 215 | 1.056 | 0.239 | 0.995 |

### Method Comparison Study

#### 8. Conclusion:

These studies demonstrate correlation and equivalent performance between the Dade
Behring N Latex HCY assay and the Dimension Vista® HCYS assay.

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Public Health Service

Food and Drug Administration 2098 Gaither Road Rockville MD 20850

Ms. Kathleen Dray-Lyons Dade Behring Inc. Glasgow Site, P.O. Box 6101 Newark, DE 19714

DEC 2 8 2006

Re: k063206 Trade/Device Name: Dimension Vista Homocysteine Flex Reagent, Dimension Vista Protein 1 Calibrator and Controls Regulation Number: 21 CFR §862.1377, §862.1150, §862.1660 Regulation Name: Urinary homocystine (non-quantitative) test system, multi-analyte calibrators, and multi-analyte controls Regulatory Class: Class II Product Codes: LPS, JIX, JJY Dated: October, 20, 2006 Received: October, 23, 2006

Dear Ms. Dray-Lyons:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820).

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific information about the application of labeling requirements to your device, or questions on the promotion and advertising of your device, please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address at http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jean M. Cooper, M.S., D.V.M.

Jean M. Cooper, M.S., D.V.M. Director Division of Chemistry and Toxicology Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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K063206

# Indications Statement

Device Name:

Dimension Vista® HCYS Flex® reagent cartridge Dimension Vista® Protein 1 Calibrator Dimension Vista® Protein 1 Control L Dimension Vista® Protein 1 Control M Dimension Vista® Protein 1 Control H

Indications for Use:

# Dimension Vista® HCYS Flex® reagent cartridge:

The HCYS method is an in vitro diagnostic test for the quantitative determination of total homocysteine in human serum, heparinized and EDTA plasma on the Dimension Vista® System. Measurements of homocysteine aid in the diagnosis and treatment of patients suspected of having hyperhomocysteinemia and homocystinuria.

## Dimension Vista® Protein 1 Calibrator

PROT1 CAL is an in vitro diagnostic product for the calibration of the C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) methods on the Dimension Vista® System.

# Dimension Vista® Protein 1 Control L, M and H

PROT1 CON L, M and H are assayed intralaboratory quality controls for assessment of precision and analytical bias in the determination of C3 Complement (C3), C4 Complement (C4), Homocysteine (HCYS), lmmunoglobulin A (IGA), Immunoglobulin G (IGG), Immunoglobulin M (IGM) and Prealbumin / Transthyretin (PREALB) on the Dimension Vista®

Prescription Use × (Per 21 CFR 801 Subpart D)

Over-The-Counter-Use (21 CFR 801)

June 150

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